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Next Generation Tactics for 510(k) Submissions

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by

Juan Carlos Serna

on 9 March 2017

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Transcript of Next Generation Tactics for 510(k) Submissions

Agenda
Challenges of a 510(k)
Anatomy of a 510(k)
Root causes of delays
How to prevent delays
Case studies
You could Google "how to write a 510(k)"
34% of the 4,000 510(k)s submitted each year are administratively incomplete
Assume $250,000 per month of burn per company
Average of 2.5 months delay
$850 million value loss
Causes of Delays
The Problem
Preparation of a 510(k):
Next Generation Tactics for 510(k) Submissions
Utilizing software for a smarter and faster submission
Case Studies
Googling "510(k) consultant" gets you here, where you'll spend a significant amount of money

Undocumented causes of delays:
Last minute changes to Indications for Use, trade name, etc.
Need for additional testing or justification is often discovered right before submission
Internal review cycles

Anatomy of a 510(k)
Shelf Life
Prior Submissions
Predicate Comparison
Test Reports
Consistent Indications
Despite all of this...
You could also try "FDA 510(k) guidance documents," where you'll return 187 results:
www.rightsubmission.com
From Feb-April 2014 FDA 510(k) RTA Audit.
Tools to work smarter and faster
MS Word templates
Defined work flows
Software
10 days from start to finish
Early start, early course correction
Technology to address anticipated problem (demo)

Last minute discussion with FDA opened door for immediate submission
10 days from start to finish
Team
Quality Engineer
VP RA/QA
Mgr RA/QA
Intern
Outside RA Consultant
Timeline (work days)
January 27, 2017 Project started
February 2, 2017 Content created in Right Submission
Software (5 days)
February 3, 2017 Attachments uploaded and verified (1 day)
February 8, 2017 Final review (3 days)
February 9, 2017 Print and ship (1 day)
February 15, 2017 FDA acceptance review complete (4 days)
How It Happened
No emailing of documents
Common collaboration platform
Focused submission
Good mix of time and talent
Frequent check-ins
Early start
Critically think through the content of each section and ask the team:
Standards Data Report (Form 3654)
Complex, time consuming, and manual process
On average, people complete 1-2 510(k) submissions in a lifetime
No defined workflow
Scattered resources
Multi-disciplinary process
VC/grant funded company, urgency was dramatic
Own predicate with established library of documents
Goal of 10 day submission was set by CEO
Early start, early course correction
1200+ FDA recognized standards
Completing form is often considered administrative and done towards end of the process
To do it correctly, it is a time-intensive process to review test protocols and reports and identify any non-conformance to standards
Starting early, early course correction
Identified testing gaps early
Obtained documentation from vendor bridging standard revisions
This would have caused a few weeks' delay if not caught early
Summary
510(k) submissions are complex
With proper planning and tools the process does not have to be painful
Delays are predictable and preventable
1. What tests and reports are we including?
2. Why are we including them, how does it support
a SE decision?

3. Are they up-to-date?
4. Is the product tested comparable to the product under review?
5. What are the weak spots and how do we address them?
Case Study 1
Case Study 2
Full transcript